Speaker 1: Welcome to scot Discust, a project of the Federalist Society
Speaker 1: for Law and Public Policy Studies. Our contributors join us
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Speaker 2: Hello, and welcome Disco Discust. I'm your host, Kyle hammerniz
Speaker 2: On behalf of the Faculty division of the Federalist Society.
Speaker 2: Today we have a moderated discussion on Food and Drug
Speaker 2: Administration versus Alliance for Hippocratic Medicine in which the Supreme
Speaker 2: Court issued a nine zero decision on June thirteenth, twenty
Speaker 2: twenty four. It is my honor to introduce our moderator
Speaker 2: and our guests today. Our moderator is Professor Teresa Stanton Collette.
Speaker 2: Teresa is a professor and the director of the Pro
Speaker 2: Life Center at the University of Saint Thomas School Law.
Speaker 2: Our first guest is Adam you Nikowski. Adam is a
Speaker 2: partner at General Bloc LLP. Our second guest is Megan Wold.
Speaker 2: Megan is a partner at Cooper and Kirk, And with that,
Speaker 2: I like to turn things over to our moderator to give.
Speaker 3: Us the background of the case.
Speaker 4: Thank you very much.
Speaker 5: I'm delighted to be a part of this program and
Speaker 5: excited to hear what our panelists have to say. We're
Speaker 5: discussing a case that I believe has been widely in
Speaker 5: some ways misreported in the press, in part because it
Speaker 5: turns on what some have been calling a legal technicality,
Speaker 5: and so rather than take up time with my comments
Speaker 5: on it, I will turn to our panelists, who have
Speaker 5: some opening statements to sort of explain how they read.
Speaker 3: The case itself. Adam, thank you for that introduction. So
Speaker 3: I'll probably just talk for a couple of minutes.
Speaker 6: I'll begin by summarizing what the case was, what the
Speaker 6: Supreme Court, and what the implications of the ruling all are,
Speaker 6: and then i'll very briefly editorialize a little bit about
Speaker 6: what I think about the ruling, which.
Speaker 3: Is maybe the marterest thing part. So most of you
Speaker 3: know what the case is about, but for those.
Speaker 6: Who don't, the plaintiffs are organizations of pro life doctors
Speaker 6: as well as a few individual pro life doctors. They
Speaker 6: filed the lawsuits in the Northern District of Texas, alleging
Speaker 6: that the FDA had acted illegally in improving MiFi prostin,
Speaker 6: which is a drug that causes abortions, in two thousand
Speaker 6: and alternatively arguing that the FDA acted illegally in loosening
Speaker 6: certain conditions of use through a series of orders in
Speaker 6: twenty sixteen, nineteen, and twenty one. And the plaintiffs, of course,
Speaker 6: to establish their entitlement to any relief at all, must
Speaker 6: have Article three standing.
Speaker 3: And so the.
Speaker 6: Plaintiffs are doctors that they do not prescribe mifipristone themselves.
Speaker 3: Do not require too, and they never alleged that they
Speaker 3: did in fact prescribe it. Their theory of standing was
Speaker 3: a little bit different.
Speaker 6: Essentially, of standing turned on injuries that would result if
Speaker 6: other doctors prescribing with for pristone.
Speaker 3: The theory was that if other.
Speaker 6: Doctors would do that, then patients would have complications and
Speaker 6: then come to emergency rooms and encounter the plaintiff doctors,
Speaker 6: whereupon the plant doctors either would experience a conscience violation
Speaker 6: or would simply be expanding resources on caring for the patients.
Speaker 6: So they'd rather expend in a different way, and the
Speaker 6: plane off organizations also alleged that they had to spend
Speaker 6: time and money essentially educating people as to the harms
Speaker 6: of MiFi pristone, which they wouldn't have had to do
Speaker 6: if MEPhI pristone hadn't been approved. So Federal District Court
Speaker 6: in Texas agreed with the planiff's arguments on both standing
Speaker 6: and the merits and held that the FDA had acted
Speaker 6: i legally in approvingly Ford pristone back in two thousand
Speaker 6: and essentially granted a complete victory to the plaintiffs. After
Speaker 6: some flori of filings both in the Fifth Circuit and
Speaker 6: in the Supreme Court, that order was stayed in its entirety,
Speaker 6: so it never actually went into effect as a result
Speaker 6: of the Supreme It's order. Ultimately, the Fifth Circuit partially
Speaker 6: affirmed the District Court as.
Speaker 3: Relevant to the Supreme Court's ruling.
Speaker 6: The court held that the planeffs did have standing, which
Speaker 6: is what opened up the door for them to obtain
Speaker 6: relief on other issues, and the Fifth Circuit ultimately concluded
Speaker 6: that the District Court was correct to hold that the
Speaker 6: FDA acty legally with respect to certain decisions in twenty
Speaker 6: sixteen and twenty twenty one loosening conditions of use, but
Speaker 6: the Fifth Circuit disagreed with the District Court's assessments with
Speaker 6: regard to the initial approval in two thousand.
Speaker 3: So in the Supreme Court, the parties litigated.
Speaker 6: Both the standing issue which the plaintiffs had prevailed on
Speaker 6: in the Fifth Circuit, as well as the merits issue
Speaker 6: that the Planets had prevailed on. The Supreme Court declined
Speaker 6: to hear the plaintiff's cross challenge to the issues on
Speaker 6: which the plane was lost on in the Fifth Circuit,
Speaker 6: and the Supreme Court ultimately ruled that the Planets did
Speaker 6: not have Article three standing in a unanimous decision by
Speaker 6: Justice Kavanaugh.
Speaker 3: So the Court walked through the three theories of.
Speaker 6: Standing that the Planets had proffered and concluded that each
Speaker 6: of them was inadequate. So, first of all, the plaintiffs
Speaker 6: alleged a conscience violation that they might experience either if
Speaker 6: they had to perform an abortion or perhaps provide medical
Speaker 6: care to someone who had complications from a method pristine abortion,
Speaker 6: and the Supreme Court rejected this argument both as a
Speaker 6: matter of law and fact.
Speaker 3: As a matter of law.
Speaker 6: The court held that there was conscience protections which would
Speaker 6: ensure that the doctors didn't personally wouldn't personally have to
Speaker 6: face the.
Speaker 3: Situation in the future.
Speaker 6: As a matter of fact, the court walked through the
Speaker 6: doctor's declarations and concluded that they didn't have any examples
Speaker 6: of situations in the past when they faced these experiences,
Speaker 6: and so they hadn't shown a subficient likelihood that they'd
Speaker 6: have to face these situations in the future. The planets
Speaker 6: also argued that there was a conscience violation that they'd
Speaker 6: experienced if they essentially were aware of other doctors performing abortions,
Speaker 6: prescribing with a pristone concluding treating complications. The court held
Speaker 6: that that type of conscience injury didn't give rise to standing.
Speaker 6: In other words, it's one thing to say it's an
Speaker 6: injury to my conscience if I have to provide medical care,
Speaker 6: but it's another to say my conscience is injured if
Speaker 6: I just witness other people doing things that I don't
Speaker 6: agree with.
Speaker 3: That's not enough for standing, the court held.
Speaker 6: The second theory of standing was simply that there was
Speaker 6: a risk that the plaintiffs would just have to take
Speaker 6: care of these patients in the future, and if they
Speaker 6: did that, they would spend time on that, they'd rather
Speaker 6: spend time on other things, and that was an injury.
Speaker 6: And the court held, both as a matter of fact
Speaker 6: and law that this this was this didn't establish standing.
Speaker 6: As a matter of fact, it was too speculative. There
Speaker 6: was no real evidence that this was going to happen.
Speaker 6: And as a matter of law, I would really open
Speaker 6: the courthouse store for doctors to be able to challenge
Speaker 6: essentially any rule eliminating a safety restriction, So the rule
Speaker 6: and gun safety were relaxed, or a speed limit were increased,
Speaker 6: doctors could sue and say, well, you know, there's many
Speaker 6: more people in the emergency room. We'll have to see them,
Speaker 6: so we're going to spend time on that. And the
Speaker 6: court basically wasn't willing to open up the courthouse.
Speaker 3: Stores in quite that way.
Speaker 6: And the final theory of standing that the plaintiffs proffered
Speaker 6: was organizational standing, essentially saying that the organization themselves would
Speaker 6: be injured basically because they'd have to spend time educating
Speaker 6: people or you know, combating the rule or advocating against it,
Speaker 6: and that would expend resources.
Speaker 3: And you know, if the WORL didn't exist, they wouldn't
Speaker 3: have to do that.
Speaker 6: As the court pointed out, that would basically obliterate all
Speaker 6: limits on standing, because anytime any agency passes a rule
Speaker 6: on anything, an organization can say, well, we're spending money
Speaker 6: advocating against it, and so that's an injury.
Speaker 3: We'd rather spend the money in other things.
Speaker 6: And you know, that limitless principle would essentially allow, as
Speaker 6: I said, any organization to sue any agency over anything,
Speaker 6: and the court decided that that expanded standing too far.
Speaker 6: So I'll just say one word about you know, about
Speaker 6: my views on the decision. I agree that I view
Speaker 6: it as a victory for the separation of powers and
Speaker 6: judicial restraint. The plaintiff's theories of standing would really broaden
Speaker 6: the category of agency actions that would be challenged by
Speaker 6: private plaintiffs. I think that the premise of Article three
Speaker 6: is that the role of the courts is to address
Speaker 6: legitimate grievances by people who have rules that personally affect them.
Speaker 3: But when plaintiffs basically.
Speaker 6: Disagree as citizens as opposed to his individual litigants, the
Speaker 6: correct remedies the political process and not litigation, and that
Speaker 6: I think is the principle that was indicated by the
Speaker 6: court in this case.
Speaker 3: So I'll turn over to my call now.
Speaker 5: Megan, please respond or give us your views of the case.
Speaker 4: Thank you.
Speaker 7: I appreciate that, and I appreciate Adam's discussion of what
Speaker 7: the opinion said. I don't really intend to add to that.
Speaker 7: He's ably covered everything that it was addressing. In this case,
Speaker 7: I filed an amicus brief on behalf of the Catholic
Speaker 7: Association along with a doctor, doctor Gracie Poso Christie, who
Speaker 7: is a practicing position in diagnostic radiology, so she reads ultrasounds,
Speaker 7: which would be the most direct relevance to this case.
Speaker 7: And I wanted to say a little bit more about
Speaker 7: the purpose of that amicust brief and the information that
Speaker 7: it was conveying, in part because I think it's going
Speaker 7: to continue to be relevant in potentially the further litigation
Speaker 7: of this case, but also another case that exists in
Speaker 7: the lower courts in the Ninth Circuit, in which states
Speaker 7: are challenging these same mithipristone regulations, and that obviously changes
Speaker 7: the standing calculation, something we can talk a little bit
Speaker 7: more about, but for purposes of our amicist brief, the
Speaker 7: goal of the brief was to convey two different things,
Speaker 7: some additional factual background that was echoing and supportive of
Speaker 7: what the plaintiffs in this case we're arguing.
Speaker 4: And the first was.
Speaker 7: The medical background about how the deregulation of methi pristone
Speaker 7: could lead to and not could but does lead to
Speaker 7: more emergency room visits from women who have taken the
Speaker 7: drug and are experiencing incomplete abortions. So, miphi PRIs stone
Speaker 7: is a drug that a woman takes, usually in my
Speaker 7: two drug cocktails, a little bit more complicated than that,
Speaker 7: but for simplicity's sake, a woman takes the drug and
Speaker 7: it causes the body to expel a pregnancy, and that
Speaker 7: process becomes increasingly risky as a pregnancy progresses. So if
Speaker 7: a person is supposed to be taken before seventy days
Speaker 7: of gestation, so when a woman's been pregnant for roughly
Speaker 7: two months, and the best way to date a pregnancy,
Speaker 7: in fact, the only effective and accurate way to know
Speaker 7: that the date of a pregnancy, to know how far
Speaker 7: along a woman is is through an in person ultrasound,
Speaker 7: But the FDA's deregulation of mefipristone did away with the
Speaker 7: requirement of an in person visit before MiFi pristone could
Speaker 7: be administered, and so the result of that is a
Speaker 7: greatly increased risk that women are self assessing their pregnancies
Speaker 7: incorrectly or with the help of a doctor, their pregnancies
Speaker 7: are being assessed incorrectly and improperly dated, quausing them to
Speaker 7: take mifipristone much later than seventy days gestation, at which
Speaker 7: point the risks increase quite significantly, the risk being that
Speaker 7: the abortion might be initiated, but it wouldn't be completed
Speaker 7: and that would necessarily require treatment in an emergency room,
Speaker 7: and in fact, FDA's packaged insert on mithi pristone says
Speaker 7: that emergency room care is the backstop or when these
Speaker 7: drugs fail to complete the abortion, which is expected in
Speaker 7: a certain percentage of cases. It's also important that women
Speaker 7: do experience ec topic pregnancies, which are non viable pregnancies
Speaker 7: located in the fallopianco rather than the uterus, and those
Speaker 7: can only be diagnosed through an in person ultrasound.
Speaker 4: As well, there are no questions you can ask the woman.
Speaker 7: There are no home pregnancy tests that can tell you
Speaker 7: whether pregnancy is a topic and taking mephipristone in the
Speaker 7: case of an ectopic pregnancy can be very risky as
Speaker 7: well and result in the necessity of emergency room care
Speaker 7: and other complications. So for this reason, our brief was
Speaker 7: trying to elucidate further some of the factual circumstances at
Speaker 7: issue here that the FDA's deregulation of mifipristone, by doing
Speaker 7: away with the requirement of an in person diagnostic visit,
Speaker 7: would increase the number of emergency room visits and complications
Speaker 7: that I'm in face. Then the second portion of the
Speaker 7: brief is really focused on Catholic hospitals. First of all,
Speaker 7: the very high percentage of hospitals in the United States
Speaker 7: that are Catholic hospitals and some of the historical background
Speaker 7: for why that is, and these hospitals do have conscience
Speaker 7: concerns when it comes to treating women in these emergency circumstances.
Speaker 7: To be clear, Catholic hospitals will always treat women who
Speaker 7: present in an emergency, regardless of whether they've taken methopristone,
Speaker 7: regardless of how they come to be in that emergency
Speaker 7: medical situation. The concern though of Catholic hospitals is that
Speaker 7: there can be very fraught moral.
Speaker 4: Circumstances at issue.
Speaker 7: For example, a woman may come in wanting to complete
Speaker 7: the abortion, but with a living unborn child, and this
Speaker 7: would create a serious moral complication for Catholic hospitals. And
Speaker 7: also in the heat of an emergency, some of these
Speaker 7: details may may not be clear. So this was the
Speaker 7: second portion of the brief, was elucidating some of the
Speaker 7: conscience problems that would arise for Catholic hospitals. Now, there
Speaker 7: were no Catholic hospitals as named plaintiffs in the case,
Speaker 7: and as with all amicust briefs, were not able to
Speaker 7: actually supplement the factual record. This was just some additional information.
Speaker 7: I don't read the court's opinion, and I think they're
Speaker 7: pretty explicit and not addressing.
Speaker 4: These kinds of the kind.
Speaker 7: Of medical evidence or weighing that evidence in the case,
Speaker 7: which makes perfect sense. You don't have a plaintiff with standing,
Speaker 7: so of course you wouldn't engage in the merits of
Speaker 7: the dispute.
Speaker 2: But what the.
Speaker 7: Court's opinion focused on was the connection between these plaintiffs
Speaker 7: and these alleged injuries, and I think it did a
Speaker 7: number of important things. I think affirming that the federal
Speaker 7: law provides conscience protections and that doctors can invoke them
Speaker 7: simply by refusing to perform medical care that violates their
Speaker 7: conscience is a helpful elaboration by the court. It wasn't
Speaker 7: entirely clear how those conscience protections would apply, or how
Speaker 7: atala another statute at issue in another case before the
Speaker 7: court right now would affect conscience protections, and so the
Speaker 7: Court did elaborate on those things, and I think very
Speaker 7: helpfully for people who have conscious objections to performing abortions.
Speaker 4: But for that reason, these.
Speaker 7: Plaintiffs couldn't assert those conscience objections because they were already
Speaker 7: protected by federal law.
Speaker 4: And then these I think the.
Speaker 7: Focus of the Court's opinion was on the attenuation and
Speaker 7: the speculative nature of these injuries, of which I was
Speaker 7: just discussing about the increase in emergency room visits, the
Speaker 7: attenuation between that connection and these plaintiffs that they were
Speaker 7: unable to substantiate that they had been seeing these increased
Speaker 7: numbers of it, they had been required to perform these
Speaker 7: additional procedures in an emergency. I don't think that the
Speaker 7: Court's decision is altogether surprising. I think it is an
Speaker 7: application of existing standing doctrines, and the Court was confronted
Speaker 7: with some very difficult questions. If these plaintiffs had standing,
Speaker 7: it would be like giving a blanket doctor created standing
Speaker 7: to challenge any public health regulation, for example. And that's
Speaker 7: this type of generalized revents that the Court does not
Speaker 7: recognize as conveying standing, and instead that the Constitution provides
Speaker 7: political avenues for complaints likelis of the plaintiffs that they
Speaker 7: can petition Congress and the President to legislatively change things,
Speaker 7: that can petition the FDA through the appropriate channels to
Speaker 7: reregulate or otherwise change this regulation that for pristone, or
Speaker 7: challenge it in the first instance. And those are the
Speaker 7: types of relief that these plaintiffs have not through the
Speaker 7: courts and through Article three standing.
Speaker 3: Megan.
Speaker 5: Is it also true though, that at least in one
Speaker 5: of the declarations filed by one of the physicians that
Speaker 5: while she herself had not encountered a woman coming into
Speaker 5: the emergency room who still had a live pregnancy, one
Speaker 5: of her partners had where the child, they detected the heartbeat,
Speaker 5: and the doctor felt in order to stop the hemorrhaging
Speaker 5: that was caused by the michipristone that the only way
Speaker 5: to do that successfully was to terminate the pregnancy. Could
Speaker 5: you explain to the listeners why that wasn't adequate given
Speaker 5: to the nature review breath?
Speaker 4: That's right.
Speaker 7: I believe that was doctor Francis who did have her
Speaker 7: declaration a description of what had what she had witnessed
Speaker 7: or was aware of happening to a partner exactly as
Speaker 7: you describe it. And I think had that circumstance happens
Speaker 7: to doctor Francis at the court may have reached a
Speaker 7: different decision, or doctor Francis her self may have had standing,
Speaker 7: But because that hadn't happened to her, it almost in
Speaker 7: some ways confirms the fact that in many hospital settings
Speaker 7: there are other doctors who can and are willing to
Speaker 7: perform these procedures, and so if one doctor has a
Speaker 7: conscious objection, there's someone else who can take over. Or
Speaker 7: perhaps that these things happened so infrequently that it wasn't
Speaker 7: likely that this would happen again. It had never happened
Speaker 7: to doctor Francis previously.
Speaker 4: That was this.
Speaker 7: I think that attenuation analysis is what caused that aspect
Speaker 7: of doctor Francis's decoration to not be enough to confer.
Speaker 5: Standing and Adam, I had a friend asking me a
Speaker 5: question when I was telling them about this program and
Speaker 5: encouraging them to watch it, and the question was, how
Speaker 5: is it that we have, you know, this plethora of
Speaker 5: cases where doctors providing abortion have been granted standing third
Speaker 5: party standing based on allegations of their patients, and these
Speaker 5: particular doctors don't have third party standing. Why didn't these
Speaker 5: doctors fall into a similar exception to the general rule
Speaker 5: of third party standing.
Speaker 6: Well, I think the difference is that when it's true
Speaker 6: that many laws abortion laws essentially say that if a
Speaker 6: doctor performs an abortion, the doctor will face certain criminal
Speaker 6: or civil consequences, and so in those cases, the doctors
Speaker 6: are directly harmed by the state action in the sense
Speaker 6: that their actions are regulated. So the classic situation in
Speaker 6: which a plaintiff has standing is when there's a regulation
Speaker 6: that's targeting them.
Speaker 3: Like you do something, you go to jail.
Speaker 6: So obviously the going to jail is an injury that
Speaker 6: affects the person that's caused by the government if it's
Speaker 6: the criminal law that's putting them in jail, and so
Speaker 6: they have standing to challenge it.
Speaker 3: They say, I don't want to go to jail, and
Speaker 3: so I'm harmed by your law that would put me there.
Speaker 6: Now, the third party standing in those cases stems from
Speaker 6: the fact that the constitutional violation is really experienced by
Speaker 6: the women. In other words, the argument is I don't
Speaker 6: want to go to jail, and my merits claim is
Speaker 6: that the constitutional rights of the women who.
Speaker 3: Would be getting the abortion would be violated.
Speaker 6: But standing is just premised on the direct entry of
Speaker 6: facing a criminal trial. The doctors in this case were
Speaker 6: not targeted by the regulation. The FDA wasn't saying, hey, doctors,
Speaker 6: you're going to go to jail unless you do something
Speaker 6: you don't want to do.
Speaker 3: The doctors were really.
Speaker 6: Complaining about the collateral effects of other doctors doing things
Speaker 6: that were legal under the FDA's rules. And so that's
Speaker 6: the difference between those two two fact patterns.
Speaker 5: And I think just of course, in writing the I'm sorry,
Speaker 5: Justice Kavanaugh and writing the opinion addressed that directly by
Speaker 5: saying that they were not compelled to do anything.
Speaker 3: Although, as Megan.
Speaker 5: Noted, the Idaho case that will be decided, this term
Speaker 5: also raises the question about what sorts of treatments might
Speaker 5: be required.
Speaker 4: Do you have any predictions on that, either.
Speaker 3: Of you very good.
Speaker 7: It's famously difficult to read the tea leaves and predict
Speaker 7: what the court is going to do in any particular case.
Speaker 4: I am on the briefs in that case, so I do.
Speaker 7: Following it very closely, and it obviously makes sense that
Speaker 7: it's going to go down to one of the last
Speaker 7: days in the term. It was a very important and
Speaker 7: significant case argued in the last week of arguments at
Speaker 7: the court. So in that sense, I'm not surprised that
Speaker 7: we're still waiting, And you know, I think I think
Speaker 7: it's just difficult to say.
Speaker 4: It's really difficult to predict.
Speaker 7: I'm optimistic that the court will say that I'm till
Speaker 7: it doesn't preempt idahose laws. But because this case was
Speaker 7: also arising and sort of an emergency posture, there will
Speaker 7: be more factual development in the lower courts, and so
Speaker 7: I also think there might be some factual issues that
Speaker 7: the Court allows the lower courts.
Speaker 4: To contend with.
Speaker 7: So that's another one of these problems with predicting the
Speaker 7: out of decisions. It's not only is it difficult to
Speaker 7: predict which way the decision goes, but because of all
Speaker 7: the different way that can be written and the complicating factors.
Speaker 7: Sometimes there aren't clear wins and losses. So I think
Speaker 7: based in oral argument, I am optimistic that Idaho's leave
Speaker 7: will not be preempted by MTALA, But I also think
Speaker 7: that there might be more life to the case and
Speaker 7: so there's going to be continued litigation about it. But
Speaker 7: again famously.
Speaker 4: Difficult to protect, and I don't want to be out
Speaker 4: on a limb doing that. Maybe Adam Fields.
Speaker 6: Otherwise, I don't feel otherwise a prediction with any educator.
Speaker 3: I mean there's some at oral argument.
Speaker 6: I think there's some back and forth about exactly what
Speaker 6: it is that Idaho's band that MTELLA would be legal.
Speaker 6: There is like some confusion in the record of exactly
Speaker 6: what the gap was between MTEL and Idaho LAT and
Speaker 6: maybe that's going to be worked out in the opinions.
Speaker 3: I don't know, but I don't really have any any
Speaker 3: educated guests.
Speaker 5: You don't think Justice Kavanaugh gag with sindy hints of
Speaker 5: FDA opinion, you know.
Speaker 3: I mean one can infer from that anything.
Speaker 2: I don't know he did with.
Speaker 6: The oral argument transcript from that case, but I find
Speaker 6: it very hard to those tea leaves are pretty vague
Speaker 6: in my opinion, Yeah.
Speaker 7: I think, you know, just as Kavanaugh noted that TALA
Speaker 7: would only apply to the hospitals, so not to individual doctors,
Speaker 7: and I think that was a point that he could
Speaker 7: make without conveying.
Speaker 4: With the like the outbum of the MTALA cases. So
Speaker 4: I agree.
Speaker 7: I don't think it really gives us any better grounds
Speaker 7: for predicting than we had before this decision came out.
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